Baxter Healthcare Corporation Recall 87739
Description: Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Baxter Healthcare Corporation Recall 87739 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1684-2021 |
| Event ID | 87739 |
| Event Description | Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. |
| Product Type | Devices |
| Distribution | Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway. |
| Quantity | 17,487 units |
| Recall Reason | There is a potential leak between the venous patient connector and patient's hemodialysis access. |
| Device Classification | 20210602 |
| Device Code Info | Product Code: 101025; Lot 1000276191, UDI: 37332414007837 |
| Center Classification Date | 20210526 |
| Recall Initiation Date | 20210414 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
| Similar To |